Guidant IRC is currently hiring on behalf of a client for the role of a Clinical Scientific Expert within the pharmaceutical industry.
- Location: Dublin/Remote
- Start date: 15 Aug 2022
- Duration of contract: 6 months
- Rate: €15 p/h
The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with company processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Integrated Clinical Trial Team (iCTT) and may support program level activities as assigned.
Responsibility for ensuring high quality clinical trial data review/insights and
analysis as directed by the Integrated Clinical Trial Team (iCTT):
- Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
- Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
- In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
- Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
- May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator's Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
- May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
- Produce training materials and provide training to iCTT.
- Support/present at study level meetings (Investigator Meetings, Data Monitoring
Committee (DMC) meetings or others), as required.
Other responsibilities include:
- Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).
- Contribute to Clinical Development and Analytics (CD&A) line function initiatives, local and/or global education and process development projects, as required.
Key Performance Indicators
Key Performance Indicators (Indicate how performance for this job will be measured)
- Performing clinical data review and insights consistently and accurately which meets the company's quality standards, timelines, and is inspection ready.
- High quality contributions to study documents (e.g., protocol, ICF, clinical sections of CTA)
- Clearly demonstrates company Values and Behaviours (i.e., Innovation, Quality, Collaboration, Performance, Courage, and Integrity.
Ideal Background (State the preferred education and experience level)
Education: Advanced degree in life sciences/healthcare (or clinically relevant degree) is
required. Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
Languages: Fluent English (oral and written)
Guidant IRC is acting as an Employment Business in relation to this vacancy.
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